QA Analyst I

Cipla USA; Fall River (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

An established industry player in pharmaceuticals is seeking a dedicated QA Analyst to ensure product quality compliance throughout manufacturing processes. This role involves in-process testing, equipment checks, and meticulous documentation of results. The ideal candidate will possess strong attention to detail and a solid understanding of cGMP practices. Join a forward-thinking company committed to improving global healthcare by contributing to the development of high-quality medicines. If you're passionate about quality assurance and ready to make a meaningful impact, this opportunity is perfect for you.

Qualifications

• Vocational training or education in pharmaceutical manufacturing preferred.
• At least three years of QA experience in GMP pharmaceutical manufacturing.

Responsibilities

• Perform in-process testing according to batch record instructions.
• Conduct equipment and room checks prior to manufacturing stages.
• Inspect in-process and finished products, documenting results accurately.

Skills

Microsoft Office

SAP

cGMP knowledge

Interpersonal skills

Attention to detail

Education

Vocational training in pharmaceutical manufacturing

3+ years of QA experience in GMP pharmaceutical manufacturing

Job description

Job Title: QA Analyst I - On-the-floor Inspector

FLSA Classification: Full-Time, Exempt Professional

Work Location: Fall River, MA

Work Hours: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Quality Assurance Manager

Salary Range: $65,000 - $90,000 (DOE)

PURPOSE

The purpose of the QA Analyst position is to monitor and ensure product quality throughout all phases of manufacturing, in compliance with specifications and SOPs.

SCOPE

This job description describes the general nature and level of work, responsibilities, and expectations. It is not exhaustive and may be modified based on department needs, training, and experience.

JOB DESCRIPTION

The QA Analyst is an individual contributor within the InvaGen Pharmaceuticals Quality Team, reporting to the Quality Assurance Manager, and may work across different departments.

Responsibilities include but are not limited to:

• Perform in-process testing according to batch record instructions.
• Conduct equipment and room checks prior to manufacturing stages.
• Execute AQL sampling and inspections.
• Inspect in-process and finished products, documenting results accurately.
• Maintain and verify standard weights and balances.
• Manage rejection of non-conforming materials.
• Monitor environmental conditions of facilities and products.
• Review engineering records and batch records for completeness and accuracy.
• Verify equipment functionality during batch runs.
• Prepare reports for customer complaints and report non-conformances.
• Perform other duties or participate in projects as assigned.

EDUCATION AND EXPERIENCE

• Vocational training or education in pharmaceutical manufacturing or related field preferred.
• At least three years of QA experience in GMP pharmaceutical manufacturing.
• Experience with MDI or parental products preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Proficiency in Microsoft Office, SAP, and related software.
• Ability to influence decision-making and work in teams.
• Strong interpersonal and communication skills.
• Current cGMP knowledge.
• Attention to detail, organization, and multitasking skills.

ABOUT THE COMPANY

Cipla is a leading global pharmaceutical company committed to high-quality medicines. We value employees' knowledge, experience, and drive to improve healthcare worldwide.

INFORMATION ABOUT INVAGEN PHARMACEUTICALS

InvaGen Pharmaceuticals, a Cipla subsidiary, develops and markets generic medicines across various therapeutic areas, based in New York.

EEO STATEMENT

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, age, sex, sexual orientation, gender identity, religion, or other protected statuses.